Acceptance and Commitment Therapy (ACT) for Family Members After a First Psychotic Attack

NCT ID: NCT06655688

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-20
• Study Completion Date: 2025-06-01

Brief Summary

This study aimed to evaluate the effect of ACT administered online to family members on self-stigmatization, coping with stress, and psychological resilience levels after the first psychotic attack (FPA).

Detailed Description

This study is a pretest, posttest, follow-up, randomized controlled experimental study. This study will be conducted with family members of individuals diagnosed with FPA who come to the psychiatry outpatient clinic of a training and research hospital. According to the results of G-power analysis, the minimum sample size of the study was calculated as 32 (intervention 16, control 16). Personal Information Form will be applied to the individuals before randomization. The computer-aided https://www.random.org/integers/ program will be used to assign the intervention and control groups without bias. It is planned that the intervention group will consist of 8-12 participants and the program will be implemented as two intervention groups. The Acceptance and Commitment Therapy (ACT) Based Intervention Program will be implemented online in eight sessions. Each session will last 60-90 minutes on average. Two sessions will be held for one group per week. The control group will not receive any intervention from the researcher. The intervention groups will be followed up with a post-test after the program is completed and three months later, while the control group will be followed up with a post-test four weeks and three months later.

In the preparation of the interventions and planning of the sessions based on ACT, the researcher utilized studies in the literature and the basic ACT training she had received. The sessions were prepared based on six components of psychological flexibility found at the basis of ACT.

Conditions

First Psychotic Attack; Family Members; Acceptance and Commitment Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental: ACT

''Acceptance and Commitment Therapy (ACT) Based Intervention Program was applied to the intervention group.

Group Type: EXPERIMENTAL

Acceptance and Commitment Therapy

Intervention Type: BEHAVIORAL

Acceptance and Commitment Therapy Based Intervention Program was applied to the intervention group in eight sessions online. Each session will last an average of 60-90 minutes. There will be two sessions for one group per week.

Control

Arm Description: Only data collection was carried out. No attempt was made by the researcher during the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acceptance and Commitment Therapy

Acceptance and Commitment Therapy Based Intervention Program was applied to the intervention group in eight sessions online. Each session will last an average of 60-90 minutes. There will be two sessions for one group per week.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Acceptance to participate in the research,
• Being responsible for the care of an individual who has been diagnosed with schizophrenia and other psychotic disorders according to DSM-5 diagnostic criteria at least six months ago and at most five years ago,
• Living with the patient for at least one year,
• First-degree relatives (mother, father, siblings, adult children and spouse),
• The home environment is suitable for online interviewing (having a computer/smartphone, internet at home, the patient can be alone in the room during the session, etc.),
• Being literate,
• Communication is not a problem.

Exclusion Criteria

• Refusal to participate in the research,
• Responsible for the care of an individual diagnosed with schizophrenia and other psychotic disorders for less than six months or more than five years according to DSM-V diagnostic criteria,
• Living with the patient for less than one year,
• No first-degree relatives (mother, father, siblings, adult children and spouse),
• The home environment is not suitable for online counseling (having a computer/smartphone, internet at home, the patient can be alone in the room during the session, etc.),
• Illiteracy,
• Communication problems.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Duygu Özer, PhD

Asst. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Duygu Özer, Asst. Prof.

Role: PRINCIPAL_INVESTIGATOR

Bartın Unıversity

Locations

Saglik Bilimleri Universitesi

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

BARU-SBF-DO-1

Identifier Type: -

Identifier Source: org_study_id